Fibromyalgia
(FM) has been reported to affect up to ten percent of the population.1
In most cases, patients are living with the constant,
unrelenting symptoms of
the condition, including widespread pain in muscles and joints, stiffness, fatigue,
sleep disturbances, irritable bowel syndrome, anxiety, depression, and cognitive
disorders, to name a few of the more common symptoms in this largely idiopathic
syndrome.

The central nervous system is implicated in FM based on the various systemic
pain, mood, sleep, and cognitive disorders ubiquitous to the diagnosis. This
type of widespread centrally mediated pain has been called Central Sensitivity
Syndrome (CSS) by University of Illinois researcher Muhammad Yunnus, MD.2 CSS
diagnoses include FM, chronic fatigue syndrome, irritable bowel syndrome, tension
and migraine headaches, primary dysmenorrhea, periodic limb movement disorder,
restless leg syndrome, temporomandibular joint disorder, and myofacial pain syndrome.
These share the common traits of pain, fatigue, poor sleep, and absence of structural
tissue pathology, and they are all predominantly found in females. Gulf War syndrome
and multiple chemical sensitivity has also been thought to be a similar, if not
the same, condition.

Ronald Melzack became interested in central pain mechanisms from his studies
of phantom limb pain, in which, for example, a left leg amputee could experience
intense pain in his missing left foot.3 He theorized the existence of an homunculus
in the cortex that represented every part of the body. It was thought that neuromodules
residing in a larger neuromatrix that comprised the homunculus normally send
pain messages to the forebrain when sufficiently stimulated by afferent pain
fibers ascending to the neuromatrix by way of the spinothalamic tract. Afferent
fibers were thought to ascend from each given part of the body to its representative
site on the homunculus. When the afferent input from a specific body site is
cut off, the neuromodule involved then puts out dendrites to other neuromodules
in an apparent attempt to make up for the new lack of stimulation. Referred pain
can result from these new connections.4

It has long been known that other kinds of input can increase the tendency of
a pain message to fire, thus lowering the pain threshold. Chief among these are
stress,5 especially stress in which the person senses a lack of personal control.6
Emotional disturbance such as anger or fear can be a real source of stress, as
can unwanted noises or lack of sleep, among many other things.

These findings combine to focus attention upon cranial electrotherapy stimulation
(CES) as a possible way to effectively alter pain pathophysiology in the brain.
Earlier studies, one on primates and one on a human seizure subject in which
receptor electrodes were placed at different sites in the brain, showed that
CES current applied across the head sent electrical impulses through every area
of the brain, canalizing especially along the limbic system.7,8 That meant that
CES stimulates the brain's pain neuromatrix directly, and it also stimulates
the limbic, or emotion center of the brain, either one or both of which could
be important in altering or raising the threshold of the pain message.

Accordingly, the best treatment for FM might well be a general treatment of the
brain rather than managing the myriad complex of individual symptoms. CES uses
between 100 microamperes and four milliamperes typically applied for a duration
of 20 minutes to an hour, daily or every other day. The prescription transcutaneous
brain stimulator is authorized for interstate marketing and export by the Food
and Drug Administration for the treatment of anxiety, depression, and insomnia,
but physicians are also prescribing it to treat severe forms of chronic pain,
since pain is processed and felt in the nervous system, which is controlled by
the brain. CES should not be confused with transcutaneous electrical nerve stimulation
(TENS), which is a much stronger current delivered in a very different waveform.
Positive results from recent studies suggest that CES may provide the relief
from symptoms of fibromyalgia that nothing else has. Patients use CES by clipping
electrodes to their earlobes, which transmit electricity directly through the
brain.

Howard Rosen, MD, an anesthesiologist/pain specialist in Monterey, California,
gave a lecture on fibromyalgia at the 2003 annual meeting of the American Academy
of Pain Management. He said that he never uses narcotics because they don't
work well enough for his patients, and once patients start narcotics, they never
come off them. His prescription: a daily dose of mild electrical stimulation
with CES.

Marilyn Lins, MD, of Utica Neuorological Surgery, Inc. in Tulsa, Oklahoma, said
that the results she has been obtaining have been miraculous. A pain specialist,
Dr. Lins reported on several fibromyalgia patients who have had sufficient pain
relief to resume normal activities with as little as two 20-minute treatments
per week. One of her patients stopped limping after only one treatment. Dr. Lins
said, "[CES] has forever changed my treatment approach. I have never experienced
results like I have had in the past two months."

Mitchell L., of Germantown, Tennessee, had suffered from fibromyalgia, arthritis,
and a sleep disorder for over six years. His physical condition worsened in spite
of nutritional supplements, diets, acupuncture, and hypnosis, none of which provided
relief from his daily pain. He could not endure the prescribed exercise program.
Medications would provide relief but cloud his mind, and eventually, they started
to strain his liver function. Within two months of daily 20-minute treatment
from a pocket-sized CES device, Mitchell's pain levels decreased, his sleep
improved, and he was able to gradually increase his exercise while limiting his
analgesics and anti-inflammatory medications. After six months, Mitchell was
sleeping and exercising enough to reduce his medications further. By ten months,
he only resorted to an occasional analgesic, usually after a particularly intense
exercise session or a long drive. Mitchell said that CES technology helped him
to reclaim his life. He is more alert and more active, with continuing signs
of improvement.

Carole L. of Verdugo City, California, uses CES twice a day for her pain from
lupus and fibromyalgia. It only took a few treatments for her to realize less
frequent awakenings and a more rested feeling when she awoke. The fogginess gave
way to a clear head, and she felt calm. When her pain increased, she was able
to relieve it in minutes. She said, "If I had not experienced this myself,
I would have difficulty believing it! I ended up having a pleasant evening instead
of being in bed with narcotic pain relievers and still feeling the pain."

Arun Kulkarni, MD, an anesthesiologist in Bombay, India, who conducted a microcurrent
electrical therapy (MET) and CES study in pain patients9 said that his fibromyalgia
cases "respond extremely well and are getting 80 to 90% relief. I am highly
convinced about CES technology now. A few of my colleagues want to own a CES
for personal use after seeing its long-term results."

A study published in the Journal of Clinical Rheumatology found
that CES technology significantly eased the pain of fibromyalgia.10 The principal
investigator, Alan
S. Lichtbroun, MD, a board-certified rheumatologist in New Jersey, found CES
was as effective as prescription drugs in relieving pain, but completely safe.
After successful clinical use of CES in the his rheumatology practice, and IRB
approval from Robert Wood Johnson Medical School, Lichtbroun undertook a double-blind,
placebo-controlled study in which 60 randomly assigned patients who completed
informed consent were given either three weeks of subsensation (100 microamperes)
CES treatment at 0.5 Hz for one hour daily (N=20), sham treatment (N=20), or
served as controls for any placebo effect in the sham-treated patients (N=20).
All patients met the diagnostic criteria set forth by the American College of
Rheumatology. The age range was from 23 to 82 years (mean of 50). There were
two men and 58 women suffering from fibromyalgia, with ages ranging from one
to 40 years (mean of 11 years).

Active CES-treated patients showed a significant improvement in tender point
scores (p<.01), and a significant improvement in self-rated scores of general
pain level (p<.002). The number of subjects rating their quality of sleep
as poor dropped from 60% at the beginning of the study to five percent (p<.02).
In addition, there were significant gains in the self-rated feeling of well-being
(p<.05) and quality-of-life (p<.03), plus fairly dramatic gains in all
six, stress-related, psychological test measures of the Profile of Mood States.
No placebo effect was found among the sham-treated patients.
After the double-blind arm of the study, 23 of the 40 control patients opted
for actual CES in an open clinical trial where they could increase the current
in accordance with the standard clinical protocols for CES. They also showed
a significant improvement in tenderpoint scores (p<.001) and in self-rated
pain (p<.005), quality of sleep (p<.001), feeling of well-being (p<.001),
and quality-of-life (p<.001). Overall, there was a 27% reduction in self-rated
pain and a 28% decrease in the tenderpoint scores of the treated group.

According to a review of 34 studies of drug treatment for fibromyalgia, adverse
effects from drugs are seen in 20% of fibromyalgia patients who use them, and
improvement from prescription drugs was reported as 28% at best.11 In addition,
unlike with the use of medication, there is no ongoing cost to the patient after
purchase of the CES device. Accordingly, Lichtbroun concluded that CES is as
effective as the drug therapies, with no negative side effects, and deserves
further consideration as an additional agent for the treatment of fibromyalgia.

The results of the electrotherapy treatment were "very surprising," says
Lichtbroun, an assistant professor at Robert Wood Johnson Medical School, in
an interview for WebMD.12 But most surprising, according to Lichtbroun, was that
only five percent of the treated patients reported having sleep disturbances
after treatment, compared with 60% who had sleep problems going into the study.
And 90% of the treated patients reported that their quality of life had improved
as a result of treatment, while 20% of the patients who were in the sham-treatment
group said their quality of life had declined.

"This technique is gaining wide acceptance at chronic pain treatment centers,"
says
Lichtbroun, "At first, I looked at this device very skeptically – and
even now I am beginning to see [that] some patients who had a marked response
at the beginning are gradually beginning to deteriorate – so again, I wondered
if the machine had lost its power. But what I've found is that patients
eventually lose their incentive to use the machine, and less frequent use appears
to mean a return of symptoms."

For therapeutic use, patients are taught how to use the devices so that "they
can undergo the treatment in their own homes, at a time that is convenient for
them," said Lichtbroun. "That's a big advantage over some other
approaches, such as massage, because it doesn't require special appointments
or a trip outside the home," he points out.

Another double-blind, placebo-controlled study using CES technology for fibromyalgia
was concluded at Louisiana State University Health Science Center in Shreveport.13
Conducted by Randall Cork, MD, PhD, et al. in the Department of Anesthesiology,
the results were similar to the Lichtbroun study. A total of 74 subjects participated:
39 were randomly assigned to the active CES treatment group and 35 to the sham-treated
group. Seventy subjects were female, with an average age of 53 (range of 22 to
75 years old). Here again, 23 of the sham subjects crossed over to an open clinical
trial after the double-blind arm of the study was completed.

Subjective pain intensity was the primary measured variable in this study. Pain
intensity, McGill pain score, tenderpoint score, profile of mood states, and
Oswestry Score measurements were taken at baseline and after three weeks. Three
weeks after crossover of the sham group, all measurements were repeated. Significant
CES effects were identified, revealing an improvement in pain intensity (p<0.01,
compared to sham; p<0.001 in sham group after crossover), McGill Score (not
significant in initial three-week trial; p<0.001 in sham group after crossover),
tenderpoint score ((p<0.01, compared to sham; P<0.001 in sham group after
crossover), and profile of mood states (p<0.01, compared to sham; p<0.001
in sham group after crossover). No significant effect was observed on Oswestry
Score, which is a quantitative disability scale rather than a functional assessment
of pain. However, one might reasonably conclude that longer follow-up would be
necessary to see changes in this subjective measure of disability among the population
of this university-based, tertiary pain-management program.

Cork concluded that his study revealed that CES could play a significant role
in the treatment of pain associated with fibromyalgia; however, the long-term
effects on disability remain to be studied. He went on to suggest that CES appears
to be an effective, well-tolerated treatment for fibromyalgia. Those involved
in the treatment of fibromyalgia should include it in their clinical armamentarium,
given the demonstrated safety of this non-invasive modality.

A peer-reviewed study published in the American Journal of Pain Management documented
treatment outcomes from 2,500 patients who responded to a survey.14 Of those,
there were 363 fibromyalgia patients, 91% of whom reported significant results
(>25% improvement) in their condition. These patients all used CES for a minimum
of three weeks. Similar results were reported for other pains, including migraine
and other headaches, back, and neck pain.

Stephen E. Plotnick, MD, a board-certified rheumatologist in Virginia Beach described
the results he obtained in about 200 patients.15 He wrote, "There's
been variable acceptance regarding the safety of using opioid analgesics to treat
noncancer pain. In FM patients, the risk-benefit ratio becomes even more complicated.
Given that CES raises the serotonin and norepinepherine levels and has a neutralizing
effect on somatic pain generators, I predict this therapy will become a mainstream
modality for reducing medication reliance and enhancing function in patients
with FM." Plotnick also presented the case report of a 40-year-old, disabled
female patient with fibromyalgia complicated by chronic lumbar strain, ankle
osteoarthritis, depression, and obstructive sleep apnea. She took escitalopram,
celecoxib, and transdermal fentanyl in 150 mcg doses, every two days. After adding
local microcurrent treatment and CES, her spinal pain went from 8 to 0, and her
ankle pain went from 10 to 6. She was then able to reduce her opiod dose by half
when she acquired a CES device for home use.

There are several models of CES depending on individual needs. Some insurance
companies will pay for the device, but many won't because it is still not
considered mainstream medicine, although the research has met the scientific
standard of being successfully replicated more than once. There have been some
well-designed pain studies in CES along with some fairly lax work by researchers,
but the Lichtbroun and Cork studies rank among the most rigorously designed.
As an initial reviewer of one of Lichtboun's studies stated, "This
article is certainly intriguing. The results are so positive in such a difficult-to-treat
population that one becomes skeptical. Nonetheless, positive results in a double-blind,
controlled study need to be taken seriously."16 This should certainly be
taken seriously now that the study has been replicated. While more longitudinal
studies need to be conducted, the best long-term management data to date is from
the results supplied by patients in the aforementioned surveys, data that represents
as much as two years of treatment with CES.14

It may be found that the low level stimulation of CES can be used to help people
who have entered into a permanent stress homeostasis from various kinds of physical
or psychological trauma, with the attendant symptoms such as pain, anxiety, insomnia,
and depression. CES might do this by helping them regain a pre-stress homeostasis
and, with it, the ability to direct their life without having to constantly expend
energies on sustaining or regaining mental and emotional balance. Once their
cortical neurophysiology is normalized, they might well experience a longer life
in which to enjoy it. Many hypotheses have been proposed in the literature. These
have primarily been theorized from the results obtained. Research has shown an
increase in beta-endorphins, serotonin, and other neurotransmitters, and EEG
and EMG studies as well as psychometrics all showed significant changes.17 Studies
are in place now at two medical schools to delineate the mechanisms through functional
MRI imaging.

Additional, defining pain studies with CES are still needed, of course, but the
quickly evolving evidence is growing ever more convincing. Unlike most pain medicines,
such as Vioxx and Oxycontin, CES has not shown a single significant negative
side effect in its treatment of pain. The only adverse events seen in 126 studies
of CES involving 4,541 subjects who had actually received treatment were skin
reactions at the electrode site (0.11%) and myogenic headaches (0.20%) due to
the uneven relaxation of cervical muscles from the current traveling across the
head.17 These are both mild and self-limiting, and they round out the CES profile
to compare it quite favorably with the other therapeutic options for the typically
refractory FM patient.